Cleared Traditional

K915066 - DISPOSABLE SKIN MARKER

K915066 is an FDA 510(k) clearance for DISPOSABLE SKIN MARKER, manufactured by American Medical Mfg., Inc.. The device is a Class 1 General & Plastic Surgery device with product code FZZ cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K915066 · American Medical Mfg., Inc. · General & Plastic Surgery device
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May 1992
Decision
188d
Days
Class 1
Risk

K915066 is an FDA 510(k) clearance for the DISPOSABLE SKIN MARKER. Classified as Marker, Skin (product code FZZ), Class I - General Controls.

Submitted by American Medical Mfg., Inc. (Calabasas, US). The FDA issued a Cleared decision on May 14, 1992 after a review of 188 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4660 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Medical Mfg., Inc. devices

FDA 510(k) Submission Details - K915066

510(k) Number K915066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1991
Decision Date May 14, 1992
Days to Decision 188 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 115d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

FZZ Device Classification - Class 1, General Controls

Product Code FZZ Marker, Skin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - FZZ Marker, Skin

All 11
Devices cleared under the same product code (FZZ) and FDA review panel - the closest regulatory comparables to K915066.
SKIN MARKER
K905143 · Aesculap, Inc. · Feb 1991
SURGICAL SKIN MARKER
K896792 · Westmark, Sterile Packing Systems, Inc. (Sps) · Dec 1989
SECURLINE SURGICAL SKIN MARKER 1000
K844865 · Precision Dynamics Corp. · Jan 1985
DISPOSABLE SKIN MARKING PEN
K843116 · E.M. Adams · Aug 1984
SCANLAN COLORMARK SKIN MARKER
K841085 · Scanlan Intl., Inc. · Jun 1984
SECURLINE SURGICAL SKIN MARKER 1000
K840820 · Precision Dynamics Corp. · Apr 1984